GMP Compliance Auditor in Oxford

Job Description

• The GMP Compliance Auditor is responsible for planning, conducting, and reporting on Good Manufacturing Practice (GMP) audits for pharmaceutical, biotechnology, medical device, and life sciences organizations.
• This role ensures that internal operations, suppliers, manufacturing sites, and quality systems comply with UK, EU, and international GMP regulations (MHRA, EU GMP, FDA 21 CFR Part 210/211, ICH guidelines, etc.).
• This position is fully remote within the UK, with occasional travel for on-site supplier audits or regulatory inspections.

Key Responsibilities

GMP Audit Planning & Execution

• Plan, prepare, and perform GMP audits for internal operations, contract manufacturers, suppliers, and third-party service providers.
• Conduct audits in accordance with MHRA, EMA/EU GMP, FDA, WHO, and ICH Q-series guidelines.
• Assess compliance of manufacturing, laboratory operations, quality systems, documentation, and operational processes.
• Identify non-conformances and areas for improvement, conducting root-cause analysis where required.

Documentation & Reporting

• Prepare detailed audit reports summarizing findings, compliance gaps, and corrective/preventive action (CAPA) recommendations.
• Track and monitor CAPA progress to ensure timely closure and continual compliance.
• Maintain audit records in accordance with QMS and regulatory requirements.

Regulatory Compliance Monitoring

• Keep updated on changes to GMP regulations, MHRA expectations, EU Annex guidelines, FDA requirements, and ICH standards.
• Support internal teams and clients during MHRA, FDA, EMA, and other regulatory inspections.
• Assist with maintaining compliance documentation, SOPs, and QMS updates.

Quality System Evaluation

• Assess key elements of GMP quality systems, including:
• Document control
• Batch record review
• Change control
• Deviation & CAPA management
• Training compliance
• Facility & equipment qualification
• Validation (process, cleaning, CSV)
• Supplier qualification
• Provide recommendations to strengthen overall quality compliance.

Cross-Functional Collaboration

• Partner with Quality Assurance (QA), QC, Manufacturing, Supply Chain, and Validation teams.
• Communicate audit outcomes to senior quality leaders and cross-functional stakeholders.
• Support training and guidance on GMP compliance best practices.

Required Qualifications

• Bachelor\’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related field.
• 3–5+ years of experience in GMP auditing, QA, regulatory compliance, or pharmaceutical manufacturing.
• Strong knowledge of: UK MHRA GMP, EU GMP (including Annexes), FDA 21 CFR Parts 210/211 & ICH guidelines (Q7, Q8, Q9, Q10, etc.).
• Experience conducting internal, supplier, or third-party GMP audits.
• Excellent understanding of pharmaceutical/life sciences quality systems.
• Strong written skills for regulatory documentation and audit reporting.